Warehouse Management

1. Subject
1. Premises
2. Security
3. Temperature and humidity control
4. Equipment
5. Personnel
6. Sanitation
7. Receipt of incoming goods
8. Warehousing of FG and Dispatch of FG
9. Packing for transportation
10. Transport
1- Premises should be of suitable size and construction to facilitate cleaning, maintenance and
orderly, segregated storage
2. PREMISES
3. 5. A secure, segregated area must be provided for the storage of controlled drugs
4. A segregated area must be provided for returned, recalled and rejected goods prior to a decision
on further action
5. Incoming materials should be Quarantine until approved by the responsible person
6. Each material should be stored separate from other materials to avoid the risk of cross
contamination
7. PREMISES
8. 6. Establish system for controlling access to the facility (including all entrances and exits) 6 STAC
Academy Maintain a control of who may enter the facilities  Storage areas should be provided with security
to prevent theft or unauthorised entry SECURITY
9. 7. Should always be a back up system in case main system fails 7 STAC Academy Control
should be adequate to ensure that all parts of the storage area are kept within the specified temperature range 
A written procedure must specify the action to be taken when this occurs  Controlled temperature storage
areas should be equipped with recorders and devices which indicate when the specific temperature range has
not been maintained  The temperature of all storage areas should be regularly monitored  All materials must
be stored at appropriate conditions as stated on the label of the material TEMPERATURE AND
HUMIDITY CONTROL
10. 8. Records of temperature and humidity in all storage areas should be reviewed and retained by a
designated responsible person 8 STAC Academy Establish a normal operating baseline of humidity if no
specific value is required  If the product spec require a specific humidity, a written procedure must specify
the action to be taken when the specified humidity range has not been maintained  The humidity of all
storage areas should be regularly monitored and recorded TEMPERATURE AND HUMIDITY CONTROL
11. 9. Recording and control equipment should be verified There should be a planned preventative
maintenance programme in place (i.e. RLAF, AHU etc.) EQUIPMENT & A computerised system(SAP)
used for stock control/distribution should be validated 9 STAC Academy Alarm set-points should be
checked on periodic intervals calibrated in intervals by appropriate methods (i.e. Electronic Balances,
Thermo hygrometer, RLAF, AHU,Dynamic pass box)
12. 10. The trainers should have established and approved qualification 10 STAC Academy The
current records of training should be in place  Personnel should be trained in relation to good storage and
distribution practice and to the duties assigned to them  There should be clearly defined job description 
There should be a sufficient number of staff  The organisation chart should be in place PERSONNEL
13. 11. ORGANIZATION CHART(STORES) 11 Head Stores Deputy Manager Stores Sr. Executive
Stores Executive Stores Assistant Stores Manager Stores STAC Academy
14. 12. Adequate toilet and changing facilities should be provided, and they should be segregated
from the main storage and order assembly areas 12 STAC Academy Material spill must be promptly
cleaned-up in accordance with the relevant health and safety requirements for materials  Smoking, eating and
drinking should be permitted only in segregated areas, and not in those areas used for the storage and handling
of final drug product  A pest control program should be in place  A written sanitation program should be in
place indicating the frequency and method of cleaning the facility(i.e. Area cleaning SOP) SANITATION
15. 13. Visually examine physical condition Visually examine delivery documents of the
consignment (i.e. delivery challan, LR Copy, excise invoice,COA etc.)The documents should be essentially
consist of following information (Name of material, Name of manufacturer, batch no, manufacturing date,
expiry date, qty. etc.)  It should be carried out according to approved adequate SOP: RECEIPT OF
INCOMING GOODS & If any discrepancies is observed in doc,material packing,vechicle condition,then
warehouse officer should bring notice this to head warehouse reject product if damage or otherwise unfit for
use verification of consignment for damage.Cross verify container labels with documents, Batchwise
segregation & QA 13 STAC Academy
16. 14. WAREHOUSING & Stores area should be suitably secured and of sufficient capacity to allow
for the safe storage Finished product shippers should be kept on pallets batchwise in defined high stacking to
avoid fails down  Storage area should be maintained or designed to ensure good storage practice  It should
be carried out according to approved adequate SOP: DISPATCH OF FG & Storage area should be
cleanhandling. & Prepare adequate shipping package to protect any damage of goods, seal pack and provide
relevant identification 14 STAC Academy Record should be maintained of storage conditioned, Records of
temperature monitoring data should be available for review dry and maintained within acceptable
temperature limit
17. 15. there should be in place documented evidence that the insulated packs ensured adequate
transport conditions with regards to: product quantity,ambient temperature, maximum delivery time. 15 STAC
Academy products requiring controlled temperature storage should be provided with insulated packs 
adequate precautions are taken against breakage  the product does not contaminate and is not contaminated
by other products or materials  the identification of the product is not lost, PACKING FOR
TRANSPORTATION Products should be packed in such a way that:
18. 16. Drug products requiring controlled temperature storage by appropriate specialised means or
should be packed with adequate insulation 16 STAC Academy The product and its package are not subjected
to unacceptable degrees of heat, cold, light, moisture or other adverse influences nor to attack by micro-
organisms or pests  Adequate precautions are taken against breakage  The product is not contaminated by
other products or materials  The safety, identity, strength, quality of the product is not lost  Products should
be transported in such a way that: TRANSPORT
19. 17. special storage and handling instructions 17 STAC Academy quantity of the product  name
of the product TRANSPORT Documents should be provided to cover all shipments. These document should
include as minimum:
20. 18. log of signature (formats) 18 STAC Academy Inventory (Inward ,stock registers) 
Complaints  Recall  preventative maintenance  calibration  pest control  cleaning operation  monitoring
temperature and humidity  Training  FG (receiving packing list,outgoing invoice,delivery challan,ARE1
copy with authorised signature)  issuing material (BMR/BPR issuance copy)  receiving material (delivery
challan,invoice,check list)  Following records should be in place: RECORDS
21. 19. https://ec.europa.eu › ... › Public health › Medicinal products for human use 19 STAC
Academy www.who.int/medicines/areas/.../GoodDistributionPractice sTRS957Annex5.pdf 
apps.who.int/medicinedocs/documents/s18675en/s18675 en.pdf  Good manufacturing practices for
pharmaceutical products. In: Quality assurance of pharmaceuticals. A compendium of guidelines and related
materials. Volume 2. Good manufacturing practices and inspection. REFERENCES
22. 20. To get training material / to invite for training on this subject, Write to ; Mr. Swapnil A. Karale
Email : swara21032015@gmail.com Mobile No.: +91 9637368948 20 STAC Academy
23. 21. 21 You learn from experience You learn better from bad experience STAC Academy
24. 22. 22 STAC Academy